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Terminated

CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO

FDA Recall Z-2946-2018 · Posted None

Recalling FirmCivco Medical Instruments Co. Inc.
Recall StatusTerminated
Product CodeITX
Date Initiated2018-07-30
Date Terminated2020-09-16
Product Quantity107 units

Reason for Recall

The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.

Firm Action

The firm initiated communication on 07/30/2018 by email and telephone calls. The firm requested return of the recalled product. Questions may be made to the Account Representative by calling CIVCO Medical Solutions, Multi-Modality Imaging at 800-445-6741 or 319-248-6757 7:00 AM - 5:30 PM CST or by email at [email protected]

Root Cause

Process control

Distribution Pattern

United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970514DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDECIVCO Medical Instruments Co., Inc. · 1997-06-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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